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    Summary
    EudraCT Number:2007-000375-42
    Sponsor's Protocol Code Number:S339.2.001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-10-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2007-000375-42
    A.3Full title of the trial
    A multi-center, double-blind, parallel-design, randomized,
    placebo-controlled, dose-ranging study to assess the efficacy and
    safety of oral recombinant microbial lipase (SLV339) in subjects
    with pancreatic exocrine insufficiency due to chronic pancreatitis
    A.4.1Sponsor's protocol code numberS339.2.001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSolvay Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/03/05/331
    D.3 Description of the IMP
    D.3.1Product nameRecombinant microbial lipase
    D.3.2Product code SLV339
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSLV339
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pancreatic exocrine insufficiency due to chronic pancreatitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009093
    E.1.2Term Chronic pancreatitis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is designed to estimate the dose-response curve for short term efficacy and safety of recombinant microbial lipase (SLV339) in subjects with maldigestion of lipids due to pancreatic exocrine insufficiency (PEI) suffering from chronic pancreatitis (CP).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria at Visit 1
    1. Signed informed consent.
    2. Subject must be ≥ 18 years and be of either sex.
    3. Pancreatic exocrine insufficiency confirmed and documented in medical history by either a pathophysiological direct or indirect pancreatic function test
    or
    Clinical symptoms of steatorrhea stool fat that resolved or improved substantially upon administration of pancreatic enzyme supplementation.
    4. Subjects are clinically stable on a stable daily dose of pancreatic enzyme supplementation for at least 3 months before the start of the study.
    5. Subjects with CP with or without partial pancreatectomy due to underlying CP; CP
    confirmed and documented in medical history by either computed tomography,
    endoscope retrograde cholangiopancreaticography, plain film with pancreatic
    calcifications, ultra-sonography (calcifications, duct dilatation), magnetic resonance
    pancreatography, endoscope ultrasound, other radiological diagnosis captured by tools such as Cambridge classification3 and /or histology.
    6. Females of non-childbearing potential (i.e., sterilized via hysterectomy or bilateral tubal ligation or at least 1 year postmenopausal) or if of childbearing potential must agree to practice effective barrier contraceptive methods, use an intrauterine device or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1.

    Inclusion Criterion at Visit 3
    1. Coefficient of fat absorption during the untreated part of the run-in period confirmed as < 80% at Visit 3.
    E.4Principal exclusion criteria
    Exclusion Criteria at Visit 1
    1. Evidence of cardiovascular, gastrointestinal/ hepatic (except CP or pancreatectomy), renal, neurological/ psychiatric, respiratory, urogenital, hematological/ immunologic, head, ears, eyes, nose or throat, dermatologic/ connective tissue, musculoskeletal, metabolic/ nutritional, drug hypersensitivity, allergy, endocrine (except diabetes mellitus), major surgery (except gall bladder removal or appendectomy) or other relevant diseases as revealed by history, physical examination, and laboratory assessments which might limit participation or completion of the study.
    2. Investigational drug intake within 90 days prior to the pre-assessment visit.
    3. Gastrointestinal stricture, ileus or acute abdomen.
    4. Any type of malignancy involving the GI tract in the last 5 years.
    5. Current excessive intake of alcohol or drug abuse.
    6. Allergic disease such as hypersensitivity pneumonitis, Aspergillus mediated asthma or allergic broncho-pulmonary aspergillosis.
    7. Allergic reaction to Aspergillus fumigatus (FastCheckPOC®).4
    8. Suspected non-compliance or non-cooperation.
    9. Stenosis of the esophagus or stomach.
    10. Mental disability or any lack of fitness that in the investigator’s opinion precludes the subject’s participation in the study.
    11. Human immunodeficiency virus infection in medical history.
    12. Subjects requiring treatment with non-permitted medication or exceeding the treatment limits of permitted medication.
    13. Subjects in acute phase of pancreatitis.
    14. Subjects with the following abnormalities of liver function tests at Visit 1 will be excluded: X3 elevation alanine transaminase (ALT) or aspartate transaminase (AST), X2 elevation of bilirubin or subjects with decompensated liver disease.
    15. Subjects with impaired renal function: creatinine ≥ 1.7 mg/dl.
    16. Subjects with coeliac disease, total gastrectomy, Crohn’s disease and small bowel surgery.
    E.5 End points
    E.5.1Primary end point(s)
    Criteria for Evaluation:
    Efficacy:
    Efficacy parameters will be CFA, CNA, stool fat concentration, stool nitrogen, stool weight, nutritional protein and fat intake and clinical symptomatology (stool frequency, stool consistency, abdominal pain, and flatulence).
    Safety:
    Safety parameters will include vital signs, physical examination, laboratory and nutritional examinations (triglycerides, cholesterol, low-density-lipoproteins, high-density-lipoproteins, retinol-binding protein, pre-albumin, albumin, transferrin, vitamin E), ADA measurements and adverse events (AEs).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose-ranging
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject visit 4 + 30 days
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 80
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-03-05
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